Z-2678-2026Class I

Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion...

Name: Z-2678-2026 Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion...
Creator: Oscor Inc.
Published: 2026-06-10
License: https://open.fda.gov/license/

Oscor Inc. / initiated 2026-06-10 / Open, Classified / root cause: design

FDA source

Oscor Inc. began a recall of Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart pump and accessories on 2026-06-10. FDA classified it as Class I and gives the reason as "Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2678-2026
Classification: Class I
Status: Open, Classified
Initiated: 2026-06-10
Posted: 2026-07-10
Recalling firm: Oscor Inc.
Product: Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart pump and accessories.
Product code: DYB Introducer, Catheter
Reason for recall: Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.
Root cause tag: design
FDA root cause: Device Design
Action: On June 10, 2026, Oscor (an Integer subsidiary ) issued a Urgent Medical Device Recall notification to affected consignees. Oscor asked consignees to take the following actions: 1. Product removal is not required, and hospitals may continue to use existing inventory. 2. Physicians should continue to use appropriate clinical awareness, monitoring, and patient support as needed. 3. Consider a device exchange or using the repositioning sheath to minimize blood loss if potential leakage from the sidearm and under the sheath cap and along the hub score lines in the hub region is observed. 4.Review the information within this letter, complete all fields, sign, and return the attached business response form (BRF) (refer to Attachment 1) to [email protected]. 5. Forward this notice to anyone in your facility that needs to be informed (i.e., those who manage, transport, store, stock, or use the subject products). 6.If any of the subject products have been forwarded to another facility, contact that facility and provide them with this notice. 7. Post a copy of this notice in a visible area for awareness.
Quantity in commerce: 355 units
Distribution: Distribution in the US state of MA
Product codes and lots: All Lots within Expiry/GTIN:00885672009793, 00813502010664

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2678-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2678-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-07-22	2026-07-10
Z-2679-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-07-22	2026-07-10
Z-2680-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-07-22	2026-07-10

Product code DYB

K122084Class IIIntroducer Set, Model Adelante-S SeriesOscor, Inc. / cleared 2012-08-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)